Minnesota blood center rejoices as FDA examines easing rules on gay, bisexual male donors
Gay and bisexual men had once been barred from donating blood due to HIV concerns. After easing the restrictions over time, the FDA may significantly ease the restrictions once again to expand the donor-eligible population.
DULUTH — A Minnesota blood center is excited to increase their donor population and reduce stigmatization after a report that the U.S. Food and Drug Administration (FDA) will consider a new policy regarding the donor eligibility of gay and bisexual men.
The policy would allow blood donations from gay and bisexual men in a monogamous relationship for at least three months prior without abstaining from sex, the Wall Street Journal first reported. A major eligibility easement, it would also revise a questionnaire to reduce stigmatization.
Restrictions for men having sex with men date back to 1983, when the FDA issued a lifetime ban on men having sex with men from donating blood. Dr. Jed Gorlin, vice president and medical director of all 10 of Minnesota’s Memorial Blood Centers, told Forum News Service that the ban was medically necessary upon its establishment.
“The FDA didnt just make up the deferrall for men having sex with men. In the U.S., about 70-80% of new cases of HIV occur in men having sex with men, but by self identification surveys, only 4-5% men would identify as men having sex with men,” Gorlin said. “Therefore, it’s at least a 20-fold risk factor.”
Gorlin acknowledged that while there are multiple ways HIV can be spread between individuals, anal sex tends to be a big driver in transmission.
“It’s likely that one of the major risk factors for acquiring HIV/AIDS is anal sex, because it increases the rate of spread because there’s bleeding,” Gorlin said.
Over the decades, as research continued into the transmissibility and treatment of HIV/AIDS, the FDA in 2015 scrapped the lifetime ban on blood donation for men having sex with men and instead installed a one-year abstinence deferral. As the balance of the supply of blood weaned during the pandemic, the FDA shortened the abstinence period to three months.
Gorlin — who also serves as chair of the American Association of Blood Bank’s Transfusion Transmitted Disease Committee — said that under the proposal, potential donors would be evaluated on a case-by-case basis with a universal questionnaire to evaluate whether any risk of HIV/AIDS exists. The questionnaire would be modeled after those used in countries including Canada, Italy, Spain and the United Kingdom.
“They ask ‘Have you had a new sex partner in the last three months?’ and if the answer is yes they ask an additional question about anal sex,” Gorlin explained.
By asking response-based follow-up questions, Gorlin said the questionnaire system could help reduce stigmatization.
“If going away from stigmatizing a particular group, we should be going towards what the specific risk is,” Gorlin said. “And yes, those questions about new partners in the past three months and a follow up about anal sex … if they do institute [the questionnaire system] those questions will be asked to everyone.”
Before the FDA can follow the data used in countries already using the questionnaire system, it will review conclusions from the Assessing Donor Variability And New Concepts in Eligibility (ADVANCE) study, which researched the blood of roughly 1,600 LGBTQ+ donors. The study’s conclusion is expected to be released by the end of the year.
“Now that the study is closed, it's going to come to a conclusion pretty quick, and that will be the ammunition that the FDA wanted to say ‘If we’re gonna set up risk-based questions, let’s have some data on what those risks are,’” Gorlin said.
Rigorous testing ensures ‘incredibly safe blood supply’
Blood donated in the United States is rigorously tested for a “whole list” of viruses, according to Gorlin, including HIV/AIDS and hepatitis B and C. When screening for HIV/AIDS in a donated unit of blood, different types of tests — antibody or molecular — are employed to ensure the blood is free from the virus that causes AIDS.
However, Gorlin noted that newer medications, such as PrEP, which are aimed at preventing the contraction of HIV may still require a temporary deferral period based on how it was administered.
“The good thing is they are very, very effective, but unfortunately, they’re not 100% effective. If taken by mouth, the current three month deferral is more than adequate,” Gorlin said. “If you’re getting a shot, the medicine lasts for up to a year or more … but it also suppresses both the antibody response and the ability for molecular tests to detect it.”
Out of an abundance of caution, and until more research can definitively confirm that the injectable PrEP does result in safe blood donations, Gorlin said a two-year deferral is in place for donors who receive the shot.
But with an abundance of testing and regulations already in place, Gorlin is confident in the safety of the United States’ blood supply.
“Between the testing and the questions, we have an incredibly safe blood supply,” Gorlin affirmed. “Using all those tests plus all those questions, there hasn't been a transfusion transmitted case of hepatitis B or C or HIV in Minnesota, to the best of my knowledge, in the 25 years that I've been at Memorial Blood Centers.”
Minnesota recovering from blood shortage, close to normal levels
As the pandemic suddenly halted the normal lifestyle of billions across the globe in early 2020, the blood industry was not immune. The closure of schools, businesses and churches — where blood drives are commonly held — shoved the nation into a blood shortage.
“Early on in the COVID pandemic, elective surgeries got canceled, people were putting off things and demand was down. But you can only put your hip or knee off for so long, so usage is coming back up,” Gorlin said.
The balance between supply and demand has been trending toward a more-normal range, but a slightly larger supply is still needed, specifically of O-negative, a universal blood type.
“We are burning out our O-negative donors,” he continued. “Normally we’d like to have a four- or five-day blood supply of O-negative, and we’ve had a two- or three-day blood supply of O-negative since September. It’s very hard to catch up.”
Memorial Blood Centers’ website currently displays an urgent need for donors of all blood types, though the message highlights they’re especially in need of O-negative blood. The need for additional donors is one reason why Gorlin believes everybody should donate, and why increased eligibility could help reduce the current need for more blood.
“To have safe blood but not have it available is not safety at all. We don’t want to depend upon the less than 5% of Americans who donate supporting everybody else,” Gorlin said. “Having blood on the shelf at all times is really critical and we truly value the donor. It’s the only donation that doesn’t come from the wallet.”
Anyone who wishes to donate blood can find a list of nearly every donation clinic by entering their zip code or city on the websites for
America’s Blood Centers
American Red Cross
or by calling their local blood bank.